1. Field of the Invention
The present invention relates to a method for diagnosing diabetes mellitus and a device therefor. The present invention can be applied in various manners to clinical diagnosis and the like, requiring rapidness and accuracy.
2. Prior Art
As a method for diagnosing diabetes mellitus, the one to determine blood glucose level is generally known. As another such method, the one to determine 1,5-anhydro-D-glucitol in plasma is also illustrated.
3. Problems to be solved by the Invention
The method via blood glucose level has limitation to the application thereof, because blood glucose level of itself is unstable and readily depends on the diet, with limitation to the application thereof. The method has a problem in that a long period of time of testing is required.
The method to determine 1,5-anhydro-D-glucitol in plasma has problems in that the conditions for such determination are hard to control; the time required for sample preparation is long; and the deproteination is needed. At the test of a sample from a diabetic patient with a lowered 1,5-anhydro-D-glucitol level, the reliability on the measurement is low. That is, the level close to the lower limit of the 1,5-anhydro-D-glucitol range of non-diabetic patients (24.6.+-.7.2 mg/liter) is proximate to the upper limit of the range of diabetic patients (7.3.+-.7.2 mg/liter). Accordingly, the method is applied only in relation with other diagnostic tests, which is a limitation to the application thereof.
Ion chromatography having a stationary phase packed with an ion exchange resin is a known method for separating and analyzing a component (ion). As such ion chromatography, there have been known ion exchange method (Anal. Chem. 1975, 47, 1801-1809); ion exclusion method (Anal. Chem. 1989, 61, 1485-1489); ion interaction method (Anal. Chem. 1982, 54, 2601-2603; Anal. Chore. 1986, 58, 2226-2233); colloid particle exclusion method (Anal. Chem. 1988, 60, 1511-1516); electrophoresis (J. Chromatog. 51 (1970), 339-342) and a combination of reverse phase chromatography and ion exclusion method (Japanese Patent Laid-open No. 4-110657), and the like. However, it has not been known any method comprising these methods to diagnose the presence or absence of diabetes mellitus.